Lead Software System Design Engineer

As a Lead System Design for the cloud-based Motion Analyzer software, you will act as a technical leader for your product through every aspect of its journey. From vision to execution, technical roadmap definition, supporting the product manager with feature prioritization and directing the development teams, you shape the future of the tool and help it grow a loyal internal and external customer base. In this role you will work with a cross-functional team that includes product marketing, sales, product development and engineering as well as partner companies.

Rockwell Automation is looking for an experienced system design lead who's passionate about helping our customers size optimal motion and drive solutions and design better machines. Ideally, you have a strong experience with industrial automation machine design, motion control, software development and a keen acumen for new technologies and market trends.

ESSENTIAL FUNCTIONS:

Functional

Lead design and architecture of cloud-based applications with thousands of users in collaboration with third party software vendors

Ensure projects are completed on time, within budget and according to quality standards.

Work closely with UX and user research groups to optimize user centric product features and workflows.

Be the key technical liaison for partner companies to drive greater adoption.

Be able to travel up to 20% of the time globally.

Leadership

Be a strong leader within a cross-functional team, developing the right product and features to fill market needs, and serve as the customer advocate interacting with functional partners including Engineering, software development partners, Program Management, Market Development, Finance, Quality and Legal.

Make appropriate & timely decisions based on current information and ensure adherence to existing company policy relating to delegation of authority.

Lead development and implementation of technical product roadmaps and improvements

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VIEW JOBS12/2/2018 12:00:00 AM2019-03-02T00:00Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol- Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Bristol-Myers Squibb Devens site is a state-of-the-art biologics manufacturing facility located on 89 acres, just 45 minutes west of Boston. It is here that we will be fulfilling our critical mission to help patients prevail over serious diseases. This 400,000 square foot complex represents the single largest capital investment in the nearly 125 year history of BMS,
$750 million, and is a key part of our strategic BioPharma transformation.
Responsible for developing and maintaining the real-time data acquisition, historization, analysis, and notification system using OSISoft PI. The candidate engage with cross functional teams to design and Maintain PI Architecture, framework, displays, and notifications.
Additionally, candidate will need to perform setup, confirmations and upgrade related activities in other enterprise data and analytics systems. Ideal candidate will effectively collaborate with global teams to understand requirements, communicate to site business units and coordinate necessary testing and implementation activities
Responsibilities
The essential functions of the job include, but are not limited to, the following:
* Continuously improve the OSIsoft PI system architecture to ensure real-time acquisition and reporting systems remain current in the ever-changing IT / Data landscape.
* Ensure stability of Asset Framework (AF), AF Analysis, Event Frames, and Notifications
* Install, configure, monitor of PI-System servers, interfaces & user tools;
* Integration of PI with manufacturing or lab instruments(E.g. Cell Analyzers) and Enterprise systems such as SAP, Process Control/ MES systems, Data Analytics Platform.
* Perform Administrative functions on OSI PI system in support of Commercial, Clinical and biologics Development facility at campus.
* Create Process Information (PI) tools for monitoring, analysis and graphical representation using PI Vision
* Create automated tools and templates as necessary for recurring tasks to improve team responsiveness and productivity
* Facilitate and actively work to ensure all quality documentation is correct, complete, and timely and recorded as appropriate
* Setup, configure and integrate different enterprise and site systems (e.g. planning and scheduling application)
* Support Enterprise System upgrades and hot-fixing efforts. Serve as the local site contact and SMEs.
* Create testing protocol and perform necessary testing related to application changes.
Position Qualifications:
Minimum :
* Bachelor's degree in Computer Science, Information Technology, or related Engineering discipline preferred.
* 2-3 years System administration and support experiences
* Working experience with Microsoft Windows Platform in a domain environment ,technical knowledge of network configuration and TCP/IP understanding
* Experience with SQL and Big data
* Experience Microsoft SQL Server database administration and Microsoft SQL Server Integration
* Able to work in both team environments as well as unsupervised in a customer environment
* Strong presentation, verbal and written communications skills
* Excellent problem-solving ability
* Ability to collect requirements, design and configure manufacturing execution systems, manufacturing intelligence tools, process control system historians and interfaces between these systems and enterprise resource planning systems
Preferred:
* 1 year of work experience in current good manufacturing practice biopharmaceutical production setting (process development and/or manufacturing technical support).
* Knowledge of the underlying scientific principles applied to the development and manufacture of biopharmaceuticals.
* Experience in Installation, configuration, and lifecycle management of the full OSIsoft PI product suite
* Experience in PI Asset Framework, implemented AF Templates and Configuration of PI with AF.
* Experience working with PI Integrator for Business analytics is a plus.
* Knowledge of the following software: DeltaV, Emerson Syncade, SAP, Maximo, LIMs, Smartlab, Microsoft Visual Studio, Microsoft IIS, Powershell
* Knowledge of additional programming language : R, C#
Knowledge of software engineering practices: Source Control, Test Driven Development, Agile Methodology, CI/CD, Front-end or full-stack web development
Bristol Myers SquibbDevensMA

VIEW JOBS12/13/2018 12:00:00 AM2019-03-13T00:00Summary:
The Technical Lead is the shift's technical expert in the execution of commercial manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs).
Responsibilities:
1. Works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. – striving for right first time through adherence of GMP activities.
2. Change control identifiers – works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation
3. Investigation identifiers – initiate investigation following alignment with QA floor
4. Communicate and resolve operational variances.
5. Serve as the "acting" Shift Supervisor/Manager in absence of Shift Supervisor/Manager – Coordinate, direct and oversee work execution and manage personnel related issues.
6. Executes real time process monitoring – including equipment and key process parameters review and work with Shift Supervisor/Manager to drive required decisions
7. Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team.
8. Participate in performance review discussion
9. Leads complex investigations on floor – drives technical issues in working with cross functional team members
10. Support real time process reports review and resolve open issues. Trend issues and strives to right first time.
11. Technical trainer for the shift – provides consistent training to the staff
12. Execute and drive continuous improvements
13. Support Tech transfer team through active participation in ensuring that new process can fit and executes in sustainable manner
14. Being resource to support routine investigations and CAPAs– author, review, approval, in case of excess investigation beyond planned capacity.
15. Assigned area owner – drive facility upkeeps
16. Adheres to Good Manufacturing Practices and standard operating procedures.
17. Weighs and checks raw materials. Assembles, cleans and sterilizes process equipment, monitors processes.
18. Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
19. Operates and trains others all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, bioreactors, harvest equipments or Downstream: Buffer equipment, glass washers, chromatography skids, membrane operations, column packing skids, etc.)
20. Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).
21. Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.
22. Assists with the coordination and implementation of special projects such as validation or complex investigations.
23. May provide scheduling and work assignment guidance to peers. Modifies group work plan, schedule or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, regularly provides training and operational guidance to other staff. Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action
Qualifications:
* B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
* A minimum of 5+ year's process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
* Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential.
* Demonstrated experience in solving complex technical issues in biologics manufacturing.
* Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
* Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
* Previous work experience where attention to detail and personal accountability were critical to success
* Demonstrates good interpersonal skills, is attentive and approachable.
* Maintains a professional and productive relationship with area management and co-workers.
* Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.
Bristol Myers SquibbDevensMA

VIEW JOBS12/12/2018 12:00:00 AM2019-03-12T00:00Summary:
Conducts and manages Quality investigations and documents investigations and CAPAs per approved SOPs. Leads investigation teams, facilitates meetings and proactively manages progression and communicates to functional area management. Monitors and reports progression of all QC Investigations and CAPAs. Proactively identifies and facilitates resolution of obstacles to timely completion. Evaluates data for system performance and development of presentations
Responsibilities:
* Conducts and manages Quality investigations into deviations and documents investigations and CAPAs per approved SOPs.
* Leads investigation teams, facilitates meetings and proactively manages progression and communicates to functional area management.
* Monitors and reports progression of all QC Investigations and CAPAs. Proactively identifies and facilitates resolution of obstacles to timely completion. Evaluates data for system performance and development of presentations
* Drafts and reviews change controls and SOPs, Work instructions and Material Specifications.
* Monitors Quality control data to proactively identify areas for program enhancement. Collaborates with functional area personnel and Quality system owners to facilitate implementation of process improvements.
* Uses Quality Risk Management and Operations Excellence principles to lead projects and resolve issues.
* Participates in audit response development and management of response timeline and CAPA identification.
* Assists in review of draft revisions to WWQCs. Conducts gap assessments and develop and monitor completion of Devens site remediation plans.
* Work within office environment.
* Works independently and if identifies issues or problems, work with Management to resolve.
* Receives majority of assignments which require the application of a defined process to complete the assignment with some variability in application depending on potential impact / scope of the assignment. As such specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly.
Some assignments will require recipient to define specific details within their own judgement with counseling from supervision as needed.
Knowledge/Skill:
* Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
* A minimum of 4 years of relevant experience in a regulated environment
* Knowledge of US and EU cGMP regulations and ICH guidance.
* Knowledge of Aegis (Discoverant), SAP, LIMS and Trackwise desirable.
Position is Monday to Friday 1st shift.
Bristol Myers SquibbDevensMA

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